FDA 510(k)

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

N.º K: K172748 · 2018-02-09

Fecha de decisión2018-02-09

Código de productoFRC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172748. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Steris Corporations. The 510(k) number is K172748.

When did VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack receive FDA 510(k) clearance?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172748.

Who is the listed applicant for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

The FDA 510(k) record lists Steris Corporations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

The FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is FRC.

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Otros registros que enlistan a Steris Corporations como solicitante

K203630BioGuard Válvulas de Aire/Agua y Succión K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System K183295Celeridad HP Indicador Químico (CI)K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag K180342SYSTEM 1E Liquid Chemical Sterilant Processing System

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Dispositivos relacionados (Código: FRC)

K260766Celeridad 5 HP Indicador Biológico (LCB052)STERIS Corporation K252680Celeridad™ 20 HP Indicador BiológicoSTERIS Corporation K251122Terragene® Bionova® BT20 Biological IndicatorTerragene K251452Celeridad 5 HP Indicador Biológico (LCB052); Paquete de Desafío Celeridad 5 HP (LCB059); Indicador Biológico Celeridad 20 HP (LCB044); Paquete de Desafío Celeridad 20 HP (LCB045)Steris K250061Celeridad IncubadoraSTERIS Corporation K250044Celeridad 5 HP Indicador Biológico (LCB052); Paquete de Desafío Celeridad 5 HP (LCB059); Indicador Biológico Celeridad 20 HP (LCB044); Paquete de Desafío Celeridad 20 HP (LCB045)STERIS Corporation

Fuente oficial

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